Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint: cardiovascular death (including fatal stroke and fatal myocardial infarction(MI)), non-fatal MI (excluding silent MI) and non-fatal stroke. [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ICMJE (submitted: May 26, 2010)

The primary endpoint is time to the first occurrence of any of the following adjudicated components of the primary composite endpoint: cardiovascular death (including fatal stroke and fatal myocardial infarction(MI)), non-fatal MI and non-fatal stroke. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years

Contraindications to background therapy according to the local label

Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight

Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus

are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner

Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake

Participation in another trial with an investigational drug within 30 days prior to informed consent

Any other clinical condition that would jeopardize patients safety while participating in this clinical trial